CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Cost-effectiveness of transanal irrigation versus conservative bowel management for spinal cord injury patients.

Spinal Cord 2009 Februrary
STUDY DESIGN: Cost-effectiveness analysis following international guidelines and taking the societal viewpoint.

OBJECTIVES: To estimate the cost-effectiveness of transanal irrigation using a self-administered irrigation system when compared with conservative bowel management.

SETTING: A randomized clinical trial was conducted at five spinal centres situated in Denmark, Germany, Italy, United Kingdom and Sweden. Estimates of resources and unit costs were made for the German health care system.

METHODS: Efficacy outcomes were drawn from a randomized controlled trial conducted in 2003-2005. Adult spinal cord-injured patients with neurogenic bowel dysfunction were randomized to 10 weeks with either transanal irrigation using Peristeen Anal Irrigation or to conservative bowel management. Costs were calculated based on results from the clinical trial and on 24 interviews conducted in Germany. Unit costs were obtained from the Federal Statistical Office Germany and product list prices.

RESULTS: When comparing outcome measures at termination, transanal irrigation significantly reduced symptoms of neurogenic bowel dysfunction. Product-related costs were higher for transanal irrigation using the self-administered system; however, costs for a carer to help with bowel management and changes/washing due to leakage were lower. For transanal irrigation, costs associated with urinary tract infections and patient time spent were reduced. Thus, the total cost to society is lower when patients use transanal irrigation. The results were shown to be robust in the sensitivity analysis.

CONCLUSION: Transanal irrigation using a self-administered system reduces symptoms of neurogenic bowel dysfunction and results in a lower total cost to society than conservative bowel management.

SPONSORSHIP: The study was supported by Coloplast A/S.

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